MalfunctionMSE
FUSA F4 (HF/PS/0.65/L)
Received Mar 29, 2011 · Event occurred Mar 4, 2011
Report 1713747-2011-00009 · MDR key 2066179
Device
Generic name
Dialyzer
Manufacturer
Ogden ManufacturingModel number
NACatalog number
0500161A
Lot number
09PU04005
Product problems
- Leak/Splash
Patient
NI
- Blood Loss
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
AN INITIAL REPORT HAS BEEN REC'D FROM A HEMODIALYSIS USER FACILITY OF A DIALYZER THAT LEAKED AT THE HEADER CAP DURING TREATMENT. THE FACILITY WAS CONTACTED AND THE FOLLOWING LIMITED INFO WAS OBTAINED. THE INVOLVED PT IS A TODDLER WEIGHING LESS THAN 20 KG AND THAT THE PT IS TREATED ON AN OUT PT BASIS. THE PT SUFFERED NO ILL EFFECT AS THE RESULT OF THE EVENT BUT WAS TREATED WITH ANTIBIOTICS. FURTHER INFO WAS NOT MADE AVAILABLE AT THIS TIME. THE SAMPLE IS AVAILABLE FOR AN EVAL.